title: Characterization and standardization of Sabin based inactivated polio vaccine: proposal for a new antigen unit for inactivated polio vaccines.
abstract: GMP-batches of Sabin-IPV were characterized for their antigenic and immunogenic properties. Antigenic fingerprints of Sabin-IPV reveal that the D-antigen unit is not a fixed amount of antigen but depends on antibody and assay type. Instead of the D-antigen unit we propose standardization of IPV based on a combination of protein amount for dose and D-antigenicity for quality of the vaccine. Although Sabin-IPV type 2 is less immunogenic than regular wild type IPV type 2, the immunogenicity (virus neutralizing titers) per microgram antigen for Sabin-IPV type 2 is in the same order as for wild type serotypes 1 and 3. The latter observations are in line with data from human trials. This suggests that a higher dose of Sabin-IPV type 2 to compensate for the lower rat immunogenicity may not be necessary.
authors.affiliation: National Institute for Public Health, Unit Vaccinology, Antonie van Leeuwenhoeklaan 9, 3720 AL Bilthoven, The Netherlands. janny.westdijk@rivm.nl
authors.forename: Janny
authors.initials: J
authors.lastname: Westdijk
authors.forename: Debbie
authors.initials: D
authors.lastname: Brugmans
authors.forename: Javier
authors.initials: J
authors.lastname: Martin
authors.forename: Aart
authors.initials: A
authors.lastname: van't Oever
authors.forename: Wilfried A M
authors.initials: WA
authors.lastname: Bakker
authors.forename: Lonneke
authors.initials: L
authors.lastname: Levels
authors.forename: Gideon
authors.initials: G
authors.lastname: Kersten
mesh_terms: D000818:Animals; D057134:Antibodies, Neutralizing / Q000097:blood / Q000276:immunology; D000914:Antibodies, Viral / Q000097:blood / Q000276:immunology; D000956:Antigens, Viral / Q000032:analysis* / Q000276:immunology; D017955:Poliovirus / Q000276:immunology; D023321:Poliovirus Vaccines / Q000032:analysis / Q000276:immunology / Q000592:standards*; D051381:Rats; D012015:Reference Standards
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D000956:Antigens, Viral; D023321:Poliovirus Vaccines